Abstract

BACKGROUND:

Safe, effective interventions to improve cancer-related fatigue (CRF) are needed because it remains a prevalent, distressing, and activity-limiting symptom. Based on pilot data, a phase III trial was developed to evaluate the efficacy of American ginseng on CRF.

METHODS:

A multisite, double-blind trial randomized fatigued cancer survivors to 2000mg of American ginseng vs a placebo for 8 weeks. The primary endpoint was the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) at 4 weeks. Changes from baseline at 4 and 8 weeks were evaluated between arms by a two-sided, two-sample t test. Toxicities were evaluated by self-report and the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) provider grading.

RESULTS:

Three hundred sixty-four participants were enrolled from 40 institutions. Changes from baseline in the general subscale of the MFSI-SF were 14.4 (standard deviation [SD] = 27.1) in the ginseng arm vs 8.2 (SD = 24.8) in the placebo arm at 4 weeks (P = .07). A statistically significant difference was seen at 8 weeks with a change score of 20 (SD = 27) for the ginseng group and 10.3 (SD = 26.1) for the placebo group (P = .003). Greater benefit was reported in patients receiving active cancer treatment vs those who had completed treatment. Toxicities per self-report and CTCAE grading did not differ statistically significantly between arms.

CONCLUSIONS:

Data support the benefit of American ginseng, 2000mg daily, on CRF over an 8-week period. There were no discernible toxicities associated with the treatment. Studies to increase knowledge to guide the role of ginseng to improve CRF are needed.

Multidimensional Fatigue Symptom Inventory–Short Form general fatigue subscale change from baseline at 4 and 8 weeks. Differences between arms at 4 and 8 weeks were carried out with a two-sample, two-sided t test. All statistical tests were two-sided.

Percentage change from baseline for general subscale of Multidimensional Fatigue Symptom Inventory–Short Form at 4 and 8 weeks by current vs postcancer treatment determined by χ2 test. All statistical tests were two-sided. The 4 week data were analyzed with a Wilcoxon signed rank test, and the 8 week data were analyzed with equal variance t-tests.